search
Back to results

TIPS Block vs Dual Subsartorial Block

Primary Purpose

Anesthesia, Local, Knee Arthropathy

Status
Not yet recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Triple Injection Perisartorius block
Dual sub sartorial block
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Local

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III Scheduled for unilateral total knee arthroplasty Exclusion Criteria: BMI > 35 kg/m2 Pre-existing neurological deficit Any disability of the non-operated limb preventing fair mobilization Infection at the site of injection Chronic opioid users/abusers

Sites / Locations

  • Alexandria Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group TIPS

Group Dual

Arm Description

patients will receive double level subsartorial block and suprasartorial LA injection at the level of the distal FT after induction of general anesthesia (GA)

patients will receive double level subsartorial canal block after induction of GA

Outcomes

Primary Outcome Measures

Postoperative resting visual analogue scale score.It's a 0-10 score where 0 is no pain and 10 is the worst pain
Resting visual analogue scale score assessment will be carried out every 4 hours during the 24 hour follow up period

Secondary Outcome Measures

Postoperative dynamic visual analogue scale score. It's a 0-10 score where 0 is no pain and 10 is the worst pain
Dynamic visual analogue scale score assessment will be carried out every 4 hours during the 24 hour follow up period
Total postoperative morphine requirements
Postoperative functional outcome
Timed Up and Go (TUG) test. Score < 10s indicates normal mobility
Postoperative functional outcome
30-second Chair Stand Test (30s-CST). The number of times the patient can stand and sit in 30 seconds

Full Information

First Posted
October 12, 2023
Last Updated
October 22, 2023
Sponsor
Alexandria University
search

1. Study Identification

Unique Protocol Identification Number
NCT06096584
Brief Title
TIPS Block vs Dual Subsartorial Block
Official Title
TIPS Block vs Dual Subsartorial Block for Total Knee Arthrolplasty: Double Blinded Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study examine adding local anesthetic injection superior to the sartorius at the level of the femoral triangle to block the intermediate femoral cutaneous nerve (IFCN) which is responsible for innervation of the anterior thigh and the proximal part of the parapatellar incision used for TKA. This may provide superior analgesia when added to dual subsartorial blockade in cases of total knee arthroplasty
Detailed Description
Introduction: Maximum pain control with regional analgesic techniques after total knee arthroplasty (TKA) is crucial for early rehabilitation after surgery. The ideal regional anesthetic technique should cover all the essential innervations of the knee joint involved in each surgical step without causing motor blockade. The investigators hypothesize that local anesthetic injection superior to the sartorius at the level of the femoral triangle may block the intermediate femoral cutaneous nerve (IFCN) which is responsible for innervation of the anterior thigh and the proximal part of the parapatellar incision used for TKA and provide superior analgesia when added to dual subsartorial blockade in cases of total knee arthroplasty. Patients will be divided into 2 groups. Group TIPS; patients will receive double level subsartorial block and suprasartorial LA injection at the level of the distal FT after induction of general anesthesia (GA). Group Dual; patients will receive double level subsartorial canal block after induction of GA. Upon arrival to the operating room (OR), a multichannel monitor will be attached to patients, followed by the administration of 2 mg midazolam IV after securing an IV cannula. Induction of anesthesia will be carried out with 2 mic/kg fentanyl, 2 mg/kg propofol and 25 mg atracurium followed by insertion of a proper size LMA. Patients will be randomly allocated into 2 groups by a computer generated program into 2 groups Group Dual: Patients will receive a combination of femoral triangle block and distal ACB. Femoral triangle block will be given just (1-2 cm) proximal to the apex of the femoral tringle which is the point at which the medial border of the sartorius muscle (STM) meets the medial border of the adductor longus muscle (ALM). Ten ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected just below the STM. Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal. At this level, femoral vessels dip into the opening of the adductor hiatus to become popliteal vessels. Sonoanatomy of this region shows the adductor magnus muscle (AMM) posteromedially, vastus medialis muscle (VMM) anterolaterally, and the STM medially. Group TIPS: Patients will receive dual injection subsartorial block and a third injection of 10 ml of 0.25 % bupivacaine superficial to the sartorius under the facia lata. Postoperatively, multimodal analgesia regimen will be continued in the form of paracetamol 1 g /8 hours and ketorolac 30 mg /8 hours intravenously for 24 hours. Intravenous morphine patient controlled analgesia will be started after induction of GA at a concentration of 0.5 mg/ml with a background infusion rate of 70 mic/kg/hr and on demand dose of 1 mg with a lockout interval of 10 minutes. Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 hour follow up period. Total postoperative morphine requirements will be measured during the postoperative follow up period. Postoperative functional outcome will be assessed using the Timed Up and Go (TUG) test and the 30-second Chair Stand Test (30s-CST).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Knee Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blinded randomized controlled study
Masking
ParticipantOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group TIPS
Arm Type
Experimental
Arm Description
patients will receive double level subsartorial block and suprasartorial LA injection at the level of the distal FT after induction of general anesthesia (GA)
Arm Title
Group Dual
Arm Type
Active Comparator
Arm Description
patients will receive double level subsartorial canal block after induction of GA
Intervention Type
Procedure
Intervention Name(s)
Triple Injection Perisartorius block
Intervention Description
Drug: Bupivacaine 0.25 % mixed with 2 mg dexamethasone. Patients will receive a combination of femoral triangle block and distal ACB. Femoral triangle block will be given just (1-2 cm) proximal to the apex of the femoral tringle which is the point at which the medial border of the sartorius muscle (STM) meets the medial border of the adductor longus muscle (ALM). Ten ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected just below the STM. Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal. At this level, femoral vessels dip into the opening of the adductor hiatus to become popliteal vessels. Sonoanatomy of this region shows the adductor magnus muscle (AMM) posteromedially, vastus medialis muscle (VMM) anterolaterally, and the STM medially Patients will receive a third injection of 10 ml of 0.25 % bupivacaine superficial to the sartorius under the facia lata
Intervention Type
Procedure
Intervention Name(s)
Dual sub sartorial block
Intervention Description
Drug: Bupivacaine 0.25 % mixed with 2 mg dexamethasone Patients will receive a combination of femoral triangle block and distal ACB. Femoral triangle block will be given just (1-2 cm) proximal to the apex of the femoral tringle which is the point at which the medial border of the sartorius muscle (STM) meets the medial border of the adductor longus muscle (ALM). Ten ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected just below the STM. Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal.
Primary Outcome Measure Information:
Title
Postoperative resting visual analogue scale score.It's a 0-10 score where 0 is no pain and 10 is the worst pain
Description
Resting visual analogue scale score assessment will be carried out every 4 hours during the 24 hour follow up period
Time Frame
1st 24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative dynamic visual analogue scale score. It's a 0-10 score where 0 is no pain and 10 is the worst pain
Description
Dynamic visual analogue scale score assessment will be carried out every 4 hours during the 24 hour follow up period
Time Frame
1st 24 hours after surgery
Title
Total postoperative morphine requirements
Time Frame
1st 24 hours after surgery
Title
Postoperative functional outcome
Description
Timed Up and Go (TUG) test. Score < 10s indicates normal mobility
Time Frame
1st 24 hours after surgery
Title
Postoperative functional outcome
Description
30-second Chair Stand Test (30s-CST). The number of times the patient can stand and sit in 30 seconds
Time Frame
1st 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III Scheduled for unilateral total knee arthroplasty Exclusion Criteria: BMI > 35 kg/m2 Pre-existing neurological deficit Any disability of the non-operated limb preventing fair mobilization Infection at the site of injection Chronic opioid users/abusers
Facility Information:
Facility Name
Alexandria Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21651
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request
IPD Sharing Time Frame
Data will be available after publication for one year
IPD Sharing Access Criteria
moustafa.abdelaziz@alexmed.edu.eg
Citations:
PubMed Identifier
22886842
Citation
Ishiguro S, Yokochi A, Yoshioka K, Asano N, Deguchi A, Iwasaki Y, Sudo A, Maruyama K. Technical communication: anatomy and clinical implications of ultrasound-guided selective femoral nerve block. Anesth Analg. 2012 Dec;115(6):1467-70. doi: 10.1213/ANE.0b013e31826af956. Epub 2012 Aug 10.
Results Reference
result
PubMed Identifier
26129851
Citation
Ludwigson JL, Tillmans SD, Galgon RE, Chambers TA, Heiner JP, Schroeder KM. A Comparison of Single Shot Adductor Canal Block Versus Femoral Nerve Catheter for Total Knee Arthroplasty. J Arthroplasty. 2015 Sep;30(9 Suppl):68-71. doi: 10.1016/j.arth.2015.03.044. Epub 2015 Jun 3.
Results Reference
result

Learn more about this trial

TIPS Block vs Dual Subsartorial Block

We'll reach out to this number within 24 hrs